What is the future of med-tech innovation in the wake of COVID-19? That was the question addressed during the Advanced Medical Technology Association’s Virtual Medtech Conference, with members of industry providing some insight. “I think … that this is going to be in many ways a turning point,” changing the way stakeholders look at devices and the evidence supporting them, said Tom O’Brien, of Johnson & Johnson’s (J&J) Ethicon unit. Read More
Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices. Read More
In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials. Read More
An artificial intelligence machine learning model that mines electronic health record data could help physicians fight the opioid epidemic by targeting non-opioid pain treatments to patients experiencing severe pain after surgery, according to new research presented at the Anesthesiology 2020 annual meeting. Read More
HONG KONG – Israel’s Ben-Gurion University of the Negev (BGU) has set up a company to further develop and commercialize its technology into a wearable device for predicting epilepsy-related seizures. Read More
LONDON – U.S. chipmaker Nvidia Inc. is investing £40 million (US$51.9 million) in building a supercomputer in Cambridge, U.K., to be dedicated to applying artificial intelligence in drug discovery and in health care. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Testing labs captured in enforcement action; Ethicon wins injunction against AIM over sutures; TGA updates class I ARTG listing requirements. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Dcao Solutions, Gentex, Icecure Medical, Masimo, Premier, Retispec, Senseonics Holdings, Spineology, Terumo, Vaxxas, Xenocor. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Chembio, Haemonetics, Histosonics, Pixcell Medical, Quidel. Read More
Keeping you up to date on recent developments in cardiology, including: Sleep apnea treatment reduces heart problems in prediabetic patients; Rats help in assessment of baroreflex; In utero 4D imaging of baby hearts could help diagnose congenital heart disease. Read More
